Mesothelioma Clinical Trials

Clinical trials are used to test emerging mesothelioma treatments and diagnostic methods. Some mesothelioma patients may be eligible for a clinical trial if they meet certain criteria. Clinical trials can be particularly helpful for late-stage patients or those that aren’t responding to conventional treatment options to extend survival and improve quality of life.

Clinical trials are ongoing and are classified as active, recruiting or completed. Recent successes with clinical trials include the immunotherapy drugs Keytruda (pembrolizumab) and Avastin (bevacizumab). Other forms of experimental treatments currently being studied are gene therapy, photodynamic therapy and various combinations of multimodality therapy.

These studies have recently wrapped up and are considered closed. Doctors review the data from completed trials to understand its level of success.

Note: Clinical trial information is provided by ClinicalTrials.gov.

Purpose of Mesothelioma Clinical Trials

Researchers continue to search for a cure for malignant mesothelioma, while also seeking improved diagnostic tools to help with early detection and improved treatment options. Clinical trials are a way for specialists to try new treatments with mesothelioma patients. This can be particularly helpful for late-stage patients with cancer that has been unresponsive to standard chemotherapy and radiation therapy options.

In order to participate in a clinical trial, patients must meet certain criteria. Each trial has its own requirements, and it’s important for patients to discuss options with their medical care team before deciding what mesothelioma treatment is best for their individual case.

Finding Clinical Trials for Mesothelioma

One of the best ways for patients to understand what clinical trials are available to them is to discuss with their medical care team. An experienced mesothelioma doctor will know what trials are recruiting, what trials the patient might be eligible for and how to begin the process.

Patients can also research clinical trials on their own. There are a variety of online resources that outline the latest options, as well as what types of treatments or diagnostic tools are being researched. Resources include:

Such resources often list the status of the clinical trial for patients to identify if they’re recruiting, in progress or closed. If recruiting or active, patients can ask their doctor if they’re eligible to participate.

Participating in Mesothelioma Clinical Trials

Clinical trials typically have certain criteria that mesothelioma patients must meet before they are eligible to participate. Criteria can be broad, such as having a cancer diagnosis, or can be specific, such as having a diagnosis of stage 4 malignant pleural mesothelioma of the sarcomatoid cell type.

Patients must let their mesothelioma specialist know of their interest to participate in a clinical trial and provide informed consent. Informed consent outlines that you agree to and understand the potential risks and benefits of the treatment. Your doctor will then outline the specifics of the study, and you will complete a form indicating your desire to join the trial.

Questions to Ask Your Doctor About Clinical Trials

What is the purpose of the clinical study?

What kinds of tests and treatments does the study involve?

What are the potential benefits and risks if I participate?

What other options do I have?

What are the potential side effects of this study?

Does this treatment require travel to a cancer center?

What are the associated costs, and will it be covered by insurance?

Will I have to be hospitalized? If so, how often and for how long?

Will I receive long-term, follow-up care as part of the study?

Has this therapy been used to treat other types of cancers?

If I am harmed as a result of the research, what treatment would I be entitled to?

Phases of a Mesothelioma Clinical Trial

If a new treatment option is successful, it may be considered for U.S. Food and Drug Administration (FDA) approval and can be readily available for patients outside of clinical trials. In order to gain FDA approval, a mesothelioma clinical trial must go through three or four phases.

Phases of Clinical Trials

Phase I: Phase I trials are conducted with a small group of patients to determine safety and effectiveness of the treatment. Doctors will study aspects like dosage levels, side effects and how the body metabolizes the drug.

Phase II: Treatment is studied with a larger group of people to get a better idea of safety and effectiveness. Phase II trials are sometimes used to compare treatments with existing treatments or rarely placebos. Promising effectiveness can then lead to phase III trials.

Phase III: Comparison studies are conducted during phase III trials to observe the effects of the new treatment on a large group of people, who are monitored closely for side effects. Improvement over a standard therapy in a phase III trial can provide evidence needed to lead to regulatory approval.

Phase IV: In some cases, treatments are approved but continue to be studied. Details of long-term use are studied, as well as testing on populations not originally tested.

Funding for Mesothelioma Clinical Trials

In most cases, clinical trials are sponsored. There are many different routes of sponsorship for mesothelioma research through clinical trials, including funding from the government, university research and investments from pharmaceutical companies.

Government funding: Cancer research has always had broad bipartisan support in Congress, leading to continued government funding throughout the years. In 2015, for example, $4.9 billion was given to the National Cancer Institute (NCI), much of which was distributed as grants to research institutions studying new cancer treatments.

University research: Many universities use government grants to conduct cancer research studies, also supplementing the funds with money of their own. This can come in the form of donations, fees to the institution or as grants from private nonprofit organizations.

Pharmaceutical companies: Drug companies are incentivized to support clinical trials, since studies are required by the U.S. Food and Drug Administration before drug approval. As a result, many drug companies put a significant amount of money towards drug research and development budgets and the conducting of clinical trials.

While clinical trials are often already funded, there are sometimes additional patient costs that should be taken into consideration. Health insurance may offer some coverage, but it depends on the patient’s individual case and coverage options. Coverage can depend based on if the patient uses a private insurance agency or if they use a government program like Medicare or Medicaid.

Typically, annual checkups, hospitalizations, preventative care and prescriptions are covered by insurance. Out-of-pocket costs can include copays or deductibles, and additional fees may arise with out-of-network care. For clinical trials, routine care expenses like hospital stays and lab work are usually covered by insurance, as long as the patient is eligible for the trial, the trial is approved and it doesn’t require out-of-network doctors and hospitals.

In addition to some coverage limitations, patients must keep all other potential fees in mind. Deciding to pursue a clinical trial could require travel and housing expenses, as well as the copays and fees for frequent check-ups and additional testing. Some trials will provide travel and housing stipends for patients who need to travel significant distances to participate.

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